Multiple sleeve method and apparatus for treating edema and other swelling disorders

ABSTRACT

An apparatus for applying pressure to a body part comprising: a first sleeve comprising a multiplicity of pressure-applying resilient protrusions configured to apply a therapeutic pressure to a surface of the body part of a patient; and a second sleeve slidably received over the first sleeve, the second sleeve configured to apply a pressure to the first sleeve, thereby increasing the therapeutic pressure applied by the first sleeve on the limb.

CROSS-REFERENCES TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 09/152,782,filed Sep. 14, 1998 (now U.S. Pat. No. 6,656,141), which was acontinuation-in-part of application Ser. No. 08/860,430, filed on Jun.24, 1997 (now U.S. Pat. No. 5,916,183), which is a continuation-in-partof application Ser. No. 08/390,866, filed on Feb. 17, 1995 (nowabandoned), all in the name of the present assignee, and all herebyincorporated by reference for all purposes.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to medical devices and methods,and in particular to a device and method for removing edema fluids froma body trunk and/or extremity such as an arm or a leg.

Breast cancer is a serious disease in women, and a variety of modalitiesare employed in its treatment. Many of these treatments result in damageto the lymphatic and/or venous system which, in turn, can cause acondition referred to as “lymphedema.” Lymphedema is the accumulation ofexcessive lymph fluid and swelling of subcutaneous tissues due to theobstruction or destruction of lymph vessels. In breast cancer patients,lymphedema occurs in the arm and results in painful swelling. Excessivefluid accumulation, referred to as edema, can also arise in the arms,legs and, trunk from a variety of other causes, including infection,radiation therapy, and other conditions which result in damage to ordestruction of portions of the lymphatic and/or venous system.

2. Description of the Background Art

A variety of devices and methods have been proposed for the treatment oflymphedema in the arms and elsewhere. Many such devices utilize asequential pump which works like a multiplicity of blood pressure cuffsextending from the shoulder to the hand, which contract and expandindividually. When pressure is exerted by any one chamber or cuff, itapplies a ‘blanket pressure’ (i.e. an annular pressure which completelycircumscribes the limb or other body portion) to the skin directlyunderneath the area of that chamber. When the pressure upon that area isreleased, a similar blanket pressure is then applied to the portion ofthe arm covered by the next adjacent chamber, and so on up the arm. Suchblanket pressures are applied sequentially from the distal to theproximal ends of the arm, with the intention of forcing the fluids upthe arm and into the trunk of the body, where existing lymph nodes canprocess them.

Another prior mode of treatment has been a double walled sheath orstocking in which air pressure is introduced between the walls tosqueeze the limb. It has been found that this and other similar systems,which rely on uniform blanket pressure application through the length ofthe afflicted limb or portions thereof, do not perform very well and infact may interfere with the desired distal-to-proximal flow of lymphaticfluid.

We have found that when a uniform and/or excessive pressure is appliedto an area for the purpose of moving fluid, the opposite effect mayresult. In particular, the application of pressure may: 1) compress theveins and lymph ducts, resulting in blockage; 2) augment capillary leak;and 3) prevent the lymphatic fluids from mobilizing.

Other approaches to treatment have included employment of a sheath thatis separated into a number of longitudinally spaced inflatable air cellsencircling the limb to be treated. These cells are successively inflatedwith uniform air pressure from the distal end to the proximal end of thesheath with the intent of promoting fluid flow in the desired direction.Such systems have been largely ineffectual, as they rely on air pressurebeing maintained at the same level or magnitude in any one of, or all,of the pressurized cells, producing a blanket effect. U.S. Pat. Nos.2,533,504 and 2,781,041 disclose examples of such systems.

Prior U.S. Pat. No. 4,370,975 discloses an apparatus for treatinglymphedema and similar fluid retention afflictions through the use of amulti-cell inflatable sheath which encompasses the swollen limb.Pressure is applied in the cells of the sheath in timed sequence fromthe distal cell to the proximal cell, the sequence of pressure appliedalso defining a decreasing gradient pressure from a maximum pressureapplied in the distal cell to a minimum pressure applied in the proximalcell when all of the cells are pressurized. Generally, for each of theadjacent cells the more distal has applied a higher pressure than themore proximal. This application of gradient pressure from distal toproximal cells in time sequence comprises a cycle, and such cycle may berepeated indefinitely to promote the flow of lymphatic fluid from theafflicted limb in a proximal direction.

The problem with the above methods is that any form of blanket pressuresuch as that applied by pneumatic or hydraulic pressure to largeafflicted areas will have at best a minimal result.

Carter, U.S. Pat. No. 5,063,910 shows an apparatus for treatingvascular, metabolic and functional imbalance of a limb by variations inpressure of a high-density fluid, such as a mercury bath, around thelimb.

The problem with this device is that the pressure applied by this meansis, in fact, a blanket-pressure, which increases with the depth of thelimb portion within the fluid bath, resulting in the disadvantagesdescribed above for al other pressure systems. Another disadvantage isthat the patient must remain immobilized during treatment.

R. W. Lilligren et al, U.S. Pat. No. 3,454,010, shows a hollow tube-likebandage for wrapping in a spiral-like manner around the limb of apatient, into which is then applied a pneumatic pressure, which isintended to drive out excess fluids prior to surgery.

Once again the pressure applied is a uniform or blanket pressure to theskin, and so is relatively ineffective to reduce swelling.

Ewen, U.S. Pat. No. 5,257,956, shows a garment for use bypost-mastectomy patients which alleviates post-operative pain anddiscomfort and facilitates normal activity during the recovery period. Apadded vest-like garment is adapted for applying comforting pressure tothe sites of removal of breast and other tissues and for holding painrelieving packages.

Again, the problem with this garment is that it applies a blanketpressure, resulting in little reduction in swelling.

Fregealle, U.S. Pat. No. 3,975,929, shows a stocking knit on a circularknitting machine which provides a gradually decreasing compressive forceon the leg of the of the wearer from the ankle upwardly to the top ofthe stocking. Again, we believe that a uniform or blanket-pressure suchas is applied by this device, is not the best method for forcing outexcess lymphedema fluids.

In all of these pressure-applied methods, the patient is immobilized upto 4 hours per day, and sometimes several days in succession, sufferingfollowing treatment and soreness of the arm for many days afterwards.

It is a well established fact that special exercises followingmastectomy help to mobilize lymphedema fluids; yet prior art devicescontribute toward immobilizing the patient, making exercising difficultor impossible. Thus resulting in a counter-producing effect.

The cost of sequential pumps including necessary limb compressionapparatus range from $500 to over $8,000. In addition, skilledtechnicians are necessary to operate it, thereby making treatment forlymphedema patients extremely expensive.

The following cited prior art references are relevant but distinguishedfrom the present invention: U.S. Pat. Nos. 2,533,504, 2,699,165,2,781,041, 2,943,859, 3,173,420, 3,454,010, 6,548,819, 3,561,435,3,728,875, 3,845,769, 3,862,629, 3,885,554, 3,942,518, 3,975,929,4,013,069, 4,030,488, 4,180,065, 4,320,746, 4,370,975, 4,374,518,4,402,312, 4,552,133, 4,583,522, 4,773,397, 4,922,893, 4,938,208,4,961,418, 5,108,426, 5,109,832, 5,117,812, 5,171,211, 5,172,689,5,228,142, 5,233,974, 5,257,956 and 5,310,400.

BRIEF SUMMARY OF THE INVENTION

The present invention provides improved apparatus and methods fortreating body parts of the patient, particularly the limbs, to relieveswelling due to lymphedema and other causes. The apparatus comprises aplurality of sleeves received one over another onto a patient's limb.The innermost sleeve comprises a therapeutic pressure sleeve. In variousembodiments of the present invention, a secondary sleeve, (which isslipped over the therapeutic pressure sleeve), comprises a thin fabriccompression sleeve. In alternate embodiments, the secondary sleevecomprises an inflatable compression sleeve. In still further alternateembodiments, both a thin fabric compression sleeve and an inflatablecompression sleeve are received over the therapeutic pressure sleeve.

When using either the thin fabric compression or inflatable compressionsleeve as the secondary sleeve, the inner therapeutic pressure sleeve isfirst pulled into position over the patient's limb. Thereafter, thesecondary sleeve is pulled into position over the therapeutic pressuresleeve. As will be explained, the therapeutic pressure sleeve exerts atherapeutic pressure at select locations on the patient's limb. Thesecondary sleeve exerts a pressure on the inner therapeutic pressurethereby increasing the therapeutic pressure on the patient's bodysurface. In certain preferred embodiments, both a thin fabriccompression sleeve and an inflatable compression sleeve aresimultaneously used, with the inflatable compression sleeve receivedover the thin fabric compression sleeve. In such embodiments, theinflatable compression sleeve exerts a pressure on the thin fabriccompression sleeve which in turn exerts a pressure on the therapeuticpressure sleeve, thereby increasing the therapeutic pressure applied tothe patient's limb.

In one preferred embodiment, the secondary sleeve is formed of a thinfabric sheet of elastically deformable material having a diametersomewhat smaller than the outer diameter of the therapeutic pressuresleeve. Accordingly, such a thin fabric compression sleeve isdimensioned to fit tightly around the therapeutic pressure sleeve. Thethin fabric compression sleeve is circumferentially stretched whenslipped into position over the therapeutic pressure sleeve. The naturalelastic tendency of the thin fabric compression sleeve to constrict willexert a pressure on the therapeutic pressure sleeve, thereby increasingthe therapeutic pressure exerted by the therapeutic pressure sleeve onthe patient's limb. In this embodiment of the secondary sleeve, thetherapeutic pressure and thin fabric compression sleeve materials areselected such that the coefficient of friction between the therapeuticpressure sleeve and thin fabric compression sleeve is sufficiently lowsuch that the thin fabric compression sleeve can easily be slipped on(and off) over the therapeutic pressure sleeve after the therapeuticpressure sleeve has already been slipped onto the patient's limb. Byusing a therapeutic pressure and a thin fabric compression sleevetogether, a higher therapeutic pressure can comfortably be applied tothe patient's limb than could comfortably be applied by one tightlyfitting elastically deformable therapeutic pressure sleeve alone. Thisis due to the fact that should only one elastically deformabletherapeutic pressure sleeve instead be used, this sleeve would have tobe dimensioned to be initially tightly received over the limb, thusbeing difficult for the patient to comfortably slip on and off.

Another advantage of using thin fabric compression sleeves is that morethan one thin fabric compression sleeve can be used simultaneously.Should two or more thin fabric compression sleeves be used, theadditional outer sleeves can be received over the inner sleeves suchthat the addition or removal of the outer sleeves can be used as a meansof pressure adjustment. Moreover, when using such thin fabric outercompression sleeves, these sleeves can be made to shorter lengths thanthe inner therapeutic pressure sleeve such that one or more of theseshorter sleeves can be received only over particular length portions ofthe patient's limb, as desired. Accordingly, bands of differenttherapeutic pressures can be simultaneously maintained at differentlocations on the patient's limb.

In another embodiment, the secondary sleeve comprises an inflationdevice such as an inflatable bladder. Inflation of such a sleeve causesthe inflatable compression sleeve to expand such that the inner surfaceof the sleeve exerts a pressure on the outer surface of the innertherapeutic pressure sleeve, thereby increasing the therapeutic pressuredelivered to the patient. When initially deflated, the inflatablecompression sleeve may therefore be dimensioned to be initially looselyreceived over the therapeutic pressure sleeve. An advantage of such asecondary inflatable sleeve received over the therapeutic pressuresleeve is that it is possible to easily adjust the therapeutic pressureapplied to the limb by adjusting the inflation pressure in theinflatable compression sleeve.

In addition, when using an inner therapeutic pressure sleeve within aperiodically inflating and deflating outer inflatable compressionsleeve, the pressure range exerted by the inflatable compression sleevecan be attenuated, while still maintaining a therapeutic pressure on thepatient's limb. Specifically, the inner therapeutic sleeve will maintaina baseline therapeutic pressure on the limb even when the outerinflatable compression sleeve is intermittently deflated. Moreover, theinner therapeutic pressure sleeve will also operate to limit the maximumpressure applied to the limb when the inflatable compression sleeve isinflated. Furthermore, a gentler rate of increase and a gentler rate ofdecrease in the net pressure applied to the limb by the inflatablecompression sleeve will be achieved by the use of an inner therapeuticpressure sleeve within an inflatable compression sleeve. Accordingly, avery beneficial therapeutic massaging effect can be generated.

In certain embodiments, the inflatable compression sleeve may haveseparate pressurized compartments such that different levels oftherapeutic pressure may be applied to different portions of thepatient's limb. The pressures in the various compartments may themselvesbe varied such that a therapeutic massaging effect is generated.

In all of the various embodiments of the present invention, the use of aplurality of separate sleeves has numerous advantages including ease ofadjusting the pressure on the patient's limb. In particular, receivingan additional sleeve or sleeves over the therapeutic pressure sleevewill increase the pressure on the patient's limb to variouspre-determined pressures dependant upon the number, dimensions, materialand/or inflation pressure of the additional outer sleeve(s). Since thepressure applied to the patient's limb can be altered by adding orremoving an outer sleeve or sleeves, or by varying the inflationpressure of the inflatable compression sleeve, optimal therapeuticpressures can be tailored to each individual patient's needs, which mayvary over time and may also vary from one location to another on thepatient's limb.

Another advantage of the present use of multiple sleeves is ease ofmanufacturing since additional fastening elements are not required to“close” or “tighten” the therapeutic pressure or secondary sleeves.Accordingly, the use of VELCRO straps or zippers is avoided. Rather, thedimension and construction of the sleeves themselves is itselfsufficient to produce an appropriately high pressure therapeutic device.

The therapeutic pressure sleeve provides a therapeutic system ofapplying pressure at select locations on the patient's limbs such thatlymphedema, edema and other swelling disorders are treated, as follows.The therapeutic pressure sleeve comprises a multiplicity ofpressure-applying resilient protrusions such as fingers or ridges whichare arranged to apply inward pressure onto a surface of the body part torelieve swelling. The protrusions will be formed from a compressiblematerial, such as foam rubber, and pressure will be applied by wrappingor otherwise compressing or collapsing the protrusions onto the bodyportion so that the fingers apply a controlled level of pressure onto alocalized area over the body part surface. In all embodiments, theprotrusions will be spaced-apart in an array so that the tips of thefingers or ridges which engage the body part surface apply pressure in aspaced-apart manner. Surprisingly, it has been found that applying sucha distributed pattern of spaced-apart pressure points or lines againstthe skin effectively reduces swelling resulting from lymphedema andother edemas in a simple and cost-effective manner. In particular, themethod and apparatus of the present invention do not block or inhibitfluid flow within the body part, further enhancing the body's ability toresorb the fluid responsible for swelling. An additional advantage ofthe device is that it is both simple and comfortable to use, enhancingpatient compliance. In the treatment of lymphedema, the apparatus andmethod of the present invention have particularly been found to permitthe release and flow back of fluid to the remaining healthy lymph nodesin a controlled manner that does not overburden such collaterallymphatic drainage.

In a specific embodiment of the present invention intended for use withthe limbs of the body, i.e., the arms and legs, the resilientprotrusions will have a height from a radially outward base to aradially inward tip in the range from 0.5 cm to 15 cm. The protrusionsare arranged in a generally cylindrical envelope with individual fingersor ridges being aligned radially inwardly with respect to the axis ofthe cylindrical envelope. The length of the cylindrical envelope willdepend on the body part being treated, e.g. from about 3 cm for a fingerto 200 cm for trunk and legs. In an apparatus intended specifically foruse with an arm, the length of the cylindrical envelope is in the rangefrom 10 cm to 90 cm, the bases of the fingers are distributed over agenerally cylindrical surface having a diameter in the range from 7.5 cmto 75 cm, and the tips of the fingers are distributed over a generallycylindrical surface having a diameter in the range from 2 cm to 15 cm.The diameters, of course, will vary widely for treatment of other bodyparts. The innermost therapeutic pressure sleeve will preferablycomprise at least an outer covering, preferably formed of material suchas NYLON, having a low coefficient of friction. The outer coveringsecures the base of the fingers over the generally cylindrical outersurface. The outer covering may generally be formed from any suitablematerial which permits the fingers or ridges to be rolled to form thegenerally cylindrical envelope. The therapeutic pressure sleeve mayfurther comprise an inner lining, preferably formed of SPANDEX. Theinner lining covers the radially inward tips of the fingers over agenerally cylindrical surface. The inner lining will be intendedprimarily for comfort and cleanliness and will be formed from anysuitably soft, relatively thin material which allows the resilientfingers to apply pressure to the body part surface.

In a more specific embodiment, the resilient protrusions will beprovided by a sheet of convoluted plastic foam which, when unrolled, hasa plurality of protuberances projecting upwardly from a base surfacethereof. The protuberances typically form cylindrical fingers or axiallyaligned ridges which are tapered to a smaller width in the directionaway from their base. The sheet of plastic foam can be rolled into thedesired cylindrical envelope configuration described above. The taperingof the protrusions is a particular advantage since it permits rolling ofthe foam rubber sheet with excessive compression of the inner surface ofthe sheet.

A principle feature of the present invention is the provision of animproved device for applying pressure to a patient's limb for thepurpose of facilitating the flow of lymphedema fluid up the limb to theshoulder or hip. This feature includes a therapeutic pressure sleevewhich can be slipped over the patient's limb and which contains amultiplicity of inwardly-pointed pressure-applying resilient fingers orridges. The fingers are preferably arranged in rows, and the rows arearranged side-by-side such that the fingers form a grid pattern havingspace around each finger and between the rows. Each finger individuallyexerts pressure against a small area of the skin, and each small area isseparated by space. The separation of individual fingers is an advantageparticular in that it allows for more precise control of pressure andpressure gradient applied to the body surface.

Another feature of the present invention is that each resilient fingerprotrusion in the therapeutic pressure sleeve provides controlledpressure against the adjacent body surface, which in turn allows thefluid to be mobilized back to the lymphatic and venous system. It isimportant that the applied pressure be sufficiently great to promoteflow of excess fluid from tissue back into vascular (venous andlymphatic) circulation and thereby reduce swelling. It is equallyimportant that the applied pressure not be so large that fluid isimpeded from returning to vascular circulation. It has been found thatan applied pressure in the range from 5 mmHg to 60 mmHg is usuallysufficient, preferably from 10 mmHg to 45 mmHg. The precise appliedpressure will usually be slightly lower than venous and lymphaticoutflow pressure, typically being about 1 mmHg to 10 mmHg below theindividual patient's venous pressure.

In accordance with the present invention, the therapeutic pressuresleeve can be fabricated to exert a pressure in the range of 5 mmHg to30 mmHg, and the secondary sleeve can be formed to exhibit an additionalpressure in the range of 5 mmHg to 30 mmHg, thereby increasing the totaltherapeutic pressure on the limb to 10 mmHg to 60 mmHg. Generally,higher maximum pressures (such as 60 mm Hg) are applied to the patient'slegs, and lower maximum pressures (such as 50 mm Hg) are applied to thepatient's arms.

The devices of the present invention have been found to be particularlysuitable for maintaining the desired controlled pressures needed for thetreatment methods. In particular, use of the therapeutic pressuresleeve's inner foam layer allows the compressive force to be appliedwhile permitting significant body movement. While other devices, such asan elastic covering, could initially be set at a desired pressure, bodymovement such as arm flexing, would result in tight constriction of thefluid circulation. Use of the resilient protuberances is particularlypreferred since it allows rolling of the device over the body partwithout excessive compression of the inner surface of the material.Other foam and resilient materials, however, could also be used, e.g.foams which are less dense near the surface which engages the body part.

Another feature of the present invention is the application of theapparatus to the hand in the form of a glove, or the chest or back, inthe form of a vest.

Further features will become apparent in the following description ofthe embodiments of this invention and from the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of the therapeutic pressure sleeve of thepresent invention fitted onto a patient's arm.

FIG. 2A is a view corresponding to FIG. 1, but with a thin fabriccompression sleeve received over the therapeutic pressure sleeve.

FIG. 2B is a view corresponding to FIG. 1, but with an inflatablecompression sleeve received over the therapeutic pressure sleeve.

FIG. 3 is a detailed perspective view of a piece of convolute plasticfoam material used in the construction of the therapeutic pressuresleeve.

FIG. 4 is a sectional view of the therapeutic pressure sleeve similar toFIG. 1, but prior to its being received over the patient's arm.

FIG. 5A is a sectional view taken along the line 5A-5A of FIG. 2A,showing the thin compression sleeve received over the therapeuticpressure sleeve, as together received over the patient's arm.

FIG. 5B is a sectional view taken along the line 5B-5B of FIG. 2B,showing the inflatable compression sleeve being in a substantiallydeflated condition.

FIG. 5C is a sectional view taken along the line 5C-5C of FIG. 2B,showing the inflatable compression sleeve being in a substantiallyinflated condition.

FIG. 6 is a perspective view of a shortened thin fabric compressionsleeve received over the therapeutic pressure sleeve.

FIG. 7 is an exploded perspective side view of a therapeutic pressuresleeve received within a thin fabric compression sleeve which is in turnreceived within an inflatable compression sleeve.

FIG. 8 is a graph of a periodic pressure applied to a patient's limb byan inflatable compression sleeve alone as compared to the periodicpressure applied to the patient's limb by an inner therapeutic pressuresleeve received within a inflatable outer compression sleeve.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows the therapeutic pressure sleeve apparatus 18 of the presentinvention fitted onto a patient's arm for treating lymphedema. (It is tobe understood, however, that the present invention can also be fitted tothe patient's leg, hand, foot or torso). As will be explained, sleeve 18is preferably received within a secondary sleeve which exerts a pressureon sleeve 18 such that an increased therapeutic pressure is applied tothe patient's body surface. Various embodiments exist for the secondarysleeve. For example, FIG. 2A shows a thin fabric compression sleeve 40received over sleeve 18 and FIG. 2B shows an inflatable compressionsleeve 50 received over sleeve 18.

As shown in FIG. 3, sleeve 18 is preferably made from a quadrangle ofconvoluted foam material 20 such as is widely used as an under-sheetlining on mattresses. Specifically, tapered quadrangle 20 of convolutedfoam is cut as shown, with the sides 21 being angle-cut so that theedges meet flush when the foam is rolled to form a tapered sleeve. Thefoam comprises a base portion 22 having a multiplicity of convolutes orupward-standing fingers 24. Fingers 24 are arranged in a grid patternformation as shown, having space 26 around each finger end 28. Since thefingers are arranged in rows, avenues or channels of space 30 exist infour different directions between and through these rows as indicated byarrows A, B, C, and D, which lie longitudinally, transversely,diagonally to the right and diagonally to the left.

As shown in cross section in FIG. 4, convoluted foam quadrangle 20 isrolled longitudinally, to form a slow-tapering funnel-shaped sleeve 18with fingers 24 facing inwardly. As can also be seen, sleeve 18 ispreferably encased in fabric comprising an inner lining 32 of SPANDEXmaterial, and an outer lining 34 of NYLON. Any other suitable materialscan also be used. Inner lining 32 and outer lining 34 are sewn togetherat each end, indicated by numeral 36 in FIG. 2A.

Foam quadrangle 20 of sleeve 18 is preferably dimensioned such that somestretching is required slip sleeve 18 over the patient's limb, yet stillbe easily slid on and off. Convoluted foam material can be made in avariety of material density, resulting in harder or softer pressurefingers. Soft fingers are used for patients requiring a lower level ofapplied pressure while more dense fingers are used for patientsrequiring high levels of applied pressure.

When the plane of convoluted foam material shown in FIG. 3, is rolledinto a sleeve with the fingers facing inwardly, the fingers and thefinger ends 28 are then located closer together as seen in FIG. 4.However, the fingers still maintain the original grid formation, andalso a space between the fingers, and between the rows of fingers stillexist in the four directions mentioned above.

A therapeutic pressure is applied by sleeve 18 as follows. When a limb,such as arm 25 (seen in FIGS. 5A, 5B and 5C) is placed inside sleeve 18,the elastomeric pressure fingers 24 press against skin 29 around andalong the full length of the arm. Shaded areas 31 indicate the regionsunder direct pressure from fingers 24. Each pressure finger 24 isseparated from the adjacent pressure finger by channel 30 against whichno pressure is applied, and which therefore form the channels forconveying lymphedema fluids. It is believed that each small area underpressure changes the interstitial pressure in the tissues, movinglymphatic fluids into and along these channels to the lymphatic andvenous drainage system.

In a first embodiment of the secondary sleeve, as is shown in FIGS. 2Aand 5A, a thin fabric compression sleeve 40 is pulled into position oversleeve 18 (after sleeve 18 has already been pulled into position overarm 25). Sleeve 18 will apply a therapeutic pressure to the patient'sbody surface (as has been described). Sleeve 40 is preferably formedfrom a thin sheet of LYCRA, or other elastically resilient, low frictionmaterial, cut and sewn together into a tapering, open-ended, generallycylindrically-shape. Sleeve 40 will preferably be dimensioned to have adiameter somewhat smaller than sleeve 18. Accordingly, sleeve 40, whenstretched into position over sleeve 18, will tend to constrict, therebyapplying a pressure to sleeve 18, thereby sleeve 18's therapeuticpressure delivered to the patient's limb. Receiving sleeve 18 intosecond sleeve 40, provides a combined pressure sufficient that thepressure applied by the fingers to the body surface is in the range from5 mmHg to 60 mmHg, preferably from 10 mmHg to 45 mmHg. When usingsleeves 18 and 40 in combination, it is preferable that sleeve 18 beconstructed to apply a pressure in the range of 5 mmHg to 30 mmHg, withsleeve 40 applying an additional pressure in the range of 5 mmHg to 30mmHg, thereby increasing the total therapeutic pressure on the limb to10 mmHg to 60 mmHg. The pressure should be applied for a time sufficientto reduce swelling, typically being employed overnight. Often, initialtreatment will involve daily (or nightly) treatments, with maintenancetreatments occurring once or twice a week.

Sleeve 40, being fabricated from a low friction material such as LYCRAcan easily be slipped on and off over the outer surface of sleeve 18.Accordingly, sleeves 18 and 40 together provide an effective system forapplying a therapeutic pressure to a patient's limb, wherein thetherapeutic pressure is higher than the pressure applied by sleeve 18alone, thereby enabling sleeve 18 to be first easily slipped over thepatient's limb and sleeve 40 to be subsequently easily slipped oversleeve 18.

In an alternate embodiment of the secondary sleeve, as shown in FIGS.2B, 5B and 5C, a secondary sleeve 50 can be received over sleeve 18.Sleeve 50 is inflatable such that when deflated, as shown in FIG. 5B, itcan loosely be received over sleeve 18, as illustrated by the presenceof an air gap 52. When inflated, as shown in FIG. 5C, sleeve 50 willexpand in volume such that any gaps between sleeve 50 and sleeve 18 willvanish, and sleeve 50 will exert an inward pressure on sleeve 18. Byincreasing the inflation pressure in sleeve 50, a greater amount ofpressure can be applied to sleeve 18, thereby increasing the therapeuticpressure applied to the patient's body surface. As can be seen in FIG.2B, sleeve 50 may optionally be divided into separate internalcompartments 54, (shown for illustration as bands around the patient'slimb), such that different inflation levels can be maintained in theseparate compartments 54. Therefore, higher pressures can be applied atlocalized regions of the limb, as desired. Moreover, an externalinflation system (not shown) can be used such that the inflation levelsof each of the various compartments can be continuously varied over timeso as to create a therapeutic massaging effect.

When using sleeve 18 within sleeve 50, sleeve 50 can be intermittentlyinflated and deflated to generate a therapeutic massaging effect on thelimb as illustrated in FIG. 8, as follows. Pressure P1 represents thepressure applied to a patient's limb when an inflatable compressionsleeve (such as sleeve 50) is used alone on the patient's limb as theinflatable compression sleeve is repeatedly inflated and deflated.Pressure P2 represents the pressure applied to a patient's limb when thepresent inner therapeutic pressure sleeve 18 is received withininflatable outer compression sleeve 50.

As can be seen, pressure P1 will rise steeply to P5 as the inflatableouter compression sleeve is inflated from a pressure of 0 mmHg topressure P5. As can also be seen, pressure P1 will also tend to fall offsteeply as the inflatable outer compression sleeve pressure is reducedfrom P5 to 0 mmHg. In accordance with the present invention, whentherapeutic compression sleeve 18 is received within an inflatablecompression sleeve 50, pressure P2 will instead maintain a baselinetherapeutic pressure P3 when inflatable compression sleeve 50 isdeflated and will exert a maximum pressure of P4 when inflatablecompression sleeve 50 is inflated. Accordingly, when using anintermittently inflating and delating compression sleeve to surround thelimb, the use of the present inner therapeutic pressure sleeve 18received therein will limit the maximum pressure applied to the limb,(from P5 to P4), and provide a baseline therapeutic pressure (P3).Furthermore, the maximum pressure change applied to the limb will beattenuated since in the absence of sleeve 18, the net pressure exertedby sleeve 50 on the limb will range from zero mmHg to P5, whereas, withsleeve 18 received within sleeve 50, the pressure will move in a muchnarrower range from P3 to P4. Accordingly, gentler and more gradualincreases and decreases in the net pressure applied to the limb will beachieved than could be achieved by the use of an inflatable compressionsleeve alone. Accordingly, a very beneficial therapeutic massagingeffect can be generated.

As is shown in FIG. 6, a shortened sleeve 40 a, (identical inconstruction to sleeve 40, but of a shorter length than sleeve 18), canbe used with sleeve 18 so as to produce a band of localized pressure ata particular region along arm 25. As can also be appreciated, aplurality of separate sleeves, each similar to sleeve 40 a may bereceived over sleeve 18 at different locations, such that varioustherapeutic pressure bands are created along arm 25. As can also beappreciated, a plurality of sleeves 40 a, (which can be of variouslengths equal or shorter than sleeve 18), can be applied one overanother at various locations on sleeve 18. Accordingly, the addition orremoval of separate sleeves 40 a can achieve increased pressures (whentwo or more sleeves 40 a are received one over another). Moreover, finerpressure adjustment can be accomplished with the addition or removal ofmultiple sleeves since each of the plurality of sleeve can be designedto increase the pressure on the limb in small increments.

In yet another embodiment of the present invention, as can be seen inthe exploded view of FIG. 7, secondary sleeves 40 and 50 can be usedtogether, with sleeve 40 preferably received within sleeve 50, as shown.Moreover, a plurality of shortened thin fabric compression sleeves 40 acould also be used together with one inflatable compression sleeve 50.Such an arrangement would offer the benefits of various therapeuticpressure bands on the patient's limb (caused by sleeves 40 a), coupledwith a massaging effect (caused by sleeve 50).

The device illustrated in FIGS. 2A and 2B has been successfully employedin a number of test cases. Although the present invention is especiallydirected toward the treatment of lymphedema, it is envisioned as alsobeing applicable for prevention and/or treatment of embolism orthrombosis, as well as for treatment of swollen limbs resulting fromvenous insufficiency.

Those skilled in the art will envision that many other possiblevariations are within its scope. For example skilled artisans willreadily be able to change the thickness or density of the foam, orlength of convolutes, or assembly different combinations of foam, ordesign a different configuration of pressure points and channels.Moreover, any suitable material can be used to cover the elastomericpressure material, including fabric printed with patterns. Other typesof foam material such as rubber, plastic air bubbles, foam air bubblesor non-convolute foam and the like can be used. Different means ofinstallation can be used. Various heights of convolutes can be used toconform to limb shape, and various number of convolutes per square footcan be used. Although not necessary for the present invention, it isalso possible to use VELCRO bands, other tightening bands, and zippersaround or along the outermost sleeve, as a system for further increasingpressure on the limb.

Accordingly, the reader is requested to determine the scope of theinvention by the appended claims and their legal equivalents, and not bythe examples which have been given.

1. A system for applying pressure to a body limb, said systemcomprising: a first sleeve comprising a cylindrical body open at bothends, having a foam lining, and being configured to be slid over thefull length of the limb and to apply an inward pressure onto the limb;and a second sleeve comprising a cylindrical body open at both ends andbeing configured to be slid wholly over the entire length of the firstsleeve such that the second sleeve will have the same length as thefirst sleeve and will apply additional inward pressure along the fulllength of the limb when the second sleeve is in place over the firstsleeve.
 2. A system as in claim 1, wherein the first sleeve isconfigured to cover an arm from the wrist to near the shoulder.
 3. Asystem as in claim 1, wherein at least the first sleeve has an outersurface with a low coefficient of friction.
 4. A system as in claim 3,wherein at least the second sleeve consists essentially of thin fabricsleeves.
 5. A system as in claim 4, wherein each of the sleevesindependently provides an inward pressure in the range from 5 mmHg to 30mmHg.
 6. A system for applying pressure to an arm, said systemcomprising: an innermost therapeutic pressure sleeve (TPS) comprising acylindrical body open at both ends having ridges formed over an innersurface and configured to be slid over the entire length of the arm fromthe shoulder to the wrist and to apply an inward pressure thereon; andat least a second sleeve comprising a cylindrical body open at both endsbeing configured to be slid wholly over the entire length of the TPSsuch that the second sleeve will have the same length as the therapeuticpressure sleeve and will apply additional inward pressure onto the limbwhen the second sleeve is in place over the therapeutic pressure sleeve.7. A system as in claim 6, wherein the TPS has an outer surface with alow coefficient of friction.
 8. A system as in claim 7, furthercomprising at least a third sleeve configured to be slid over the secondsleeve to apply additional inward pressure onto the limb.
 9. A system asin claim 8, wherein the second and third sleeves consist essentially ofthin fabric sleeves.
 10. A system as in claim 9, wherein each of the TPSand sleeves independently provide an inward pressure in the range from 5mmHg to 30 mmHg when placed over the arm.